- Industry: Government
- Number of terms: 2516
- Number of blossaries: 0
- Company Profile:
The FDA is responsible for pprotecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the US food supply, cosmetics, dietary supplements, and products that give off radiation.
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are extracted from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
In general, the term "drugs" includes therapeutic biological products.
Industry:Pharmaceutical
A brand name drug is a drug marketed under a proprietary, trademark-protected name.
Industry:Pharmaceutical
The Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. For example, Chemical Type 1 is assigned to an active ingredient that has never before been marketed in the United States in any form. (list of Chemical Types and their meanings)
Industry:Pharmaceutical
Products listed in Drugs@FDA as "discontinued" are approved products that have never been marketed, have been discontinued from marketing, are for military use, are for export only, or have had their approvals withdrawn for reasons other than safety or efficacy after being discontinued from marketing.
Industry:Pharmaceutical
A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.
Industry:Pharmaceutical
A drug is defined as:
* A substance recognized by an official pharmacopoeia or formulary.
* A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
* A substance (other than food) intended to affect the structure or any function of the body.
* A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
* Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)
Industry:Pharmaceutical
The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients.
Industry:Pharmaceutical
The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place.
Industry:Pharmaceutical
This number, also known as the NDA (new drug application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States. One drug can have more than one application number if it has different dosage forms or routes of administration
Industry:Pharmaceutical
A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product.
Industry:Pharmaceutical
